In 2018 Triple Innovation completed a Government sponsored project with a Queensland based Clinical Research Organisation (CRO) to develop a workforce strategy to lift its capacity and capabilities to conduct industry-sponsored drug and device clinical trials in regional locations. The CRO was expanding quickly and wanted to understand capacity and capability bottlenecks more precisely through industry insight and validated financial modelling. These skills did not exist in-house but senior management understood that reducing their business to a set of clear time and cost ratios for Principal Investigators and key CRO staff would dictate the number, type, duration and intensity of clinical trials they could undertake in a year. This would highlight the Principal Investigator (PI) and staff ratios they needed to resource and complete each trial successfully, and profitably.
Building a critical mass within the clinical trials ecosystem was expected to have a positive effect on regional employment and business growth in the 3 years to 2021. And it would put the CRO on a path of sustained profitability.
This project involved 17 stakeholder consultations across stakeholder groups involved in the clinical trial industry, including training providers and tertiary institutions. How the CRO did business was analysed and modelled across the CRO’s past and existing pipeline of Phase 1, Phase II and Phase III clinical trial activity. This resulted in a user friendly forecast economic model able to test core assumptions, identify regional bottlenecks to growth and the terminal limits to the number and profitability of clinical trials that could be conducted if bottlenecks could be favourably and cost effectively resolved. This model underpinned the development of 4 workforce expansion strategies and 4 clinical trials expansion strategies. The key outcomes of this Project included the following:
1. The workforce requirements for the conduct of clinical trials can be reduced to a trial capacity formula as part of an economic model with validated assumptions.
2. PI capacity can be expanded by identifying, training and resourcing suitable GP practices, but formalised off-site and on-site / on-line training and structured support are needed to support new PI’s.
3. Without adequate support, new PI’s are less likely to deliver high quality clinical research and less likely to conduct follow on trials
4. Formalised training and internal processes are needed to deliver structured support to new Principal Investigators and develop new CT coordinators.
The critical barriers to increasing the clinical trial workforce among students include:
1. Promotion of awareness of the clinical trial industry to students
2. Embedding clinical trials discipline within university curricula
3. Exposure to the clinical trial industry through existing work placement pathways
4. Incentives to encourage initial industry placements and see the clinical trial industry as a full-time career option
5. Incentives to encourage more placements and uptake of qualified junior staff who would be more readily accepted within the clinical trial industry
The clinical trial industry is projected to grow at a CAGR 12.4% globally to reach $57Bn in 2020. If equipped with skilled staff and infrastructure, an opportunity exists for Australia’s regional communities to promote both patient access to cutting edge health innovation and capture the economic benefits associated with clinical trials. Every $1 spent in clinical trials is said to generate another $5 in downstream activities.
All Project recommendations were adopted. As a result our client has developed a profitable Phase 1 clinical trials facility but has also expanded its Phase II CT work confident that it has a set of strategies to resolve key operational bottlenecks.